11 April 2018

Study shows antiepileptics enhance dementia risk

Researchers at the University of Eastern Finland and the German Center for Neurodegenerative Diseases have discovered that continuous use of antiepileptic drugs increases the risk of dementia and Alzheimer’s disease.

Antiepileptics are used to treat neuropathic pain, bipolar and generalised anxiety disorders.

When administered for more than a year, the drugs were found to have increased the dementia risk by 30% and Alzheimer’s risk by 15% in German and Finnish datasets respectively.

The study revealed that the risk was higher with antiepileptic drugs that lead to cognitive function impairment, as they increased dementia risk by 60% and Alzheimer’s by 20%.

It was further observed that higher doses of such drugs led to high risk of dementia, while other antiepileptics that do not result in cognitive impairment were not associated with the risk.

University of Eastern Finland senior researcher Heidi Taipale said: “More research should be conducted into the long-term cognitive effects of these drugs, especially among older people.”

The study involved 70,718 Finnish subjects with Alzheimer’s disease and 282,862 controls, and 20,325 German dementia patients and 81,300 controls.

Part of the nationwide register-based study, the Finnish dataset included patients diagnosed between 2005 and 2011, while the German dataset was from 2004 to 2011.

Regularity of use, dose and comparison of the risk between antiepileptic drugs with and without cognitive-impairing effects were examined during the study.

11 April 2018

UK to provide £75m to advance prostate cancer treatment

UK Prime Minister Theresa May has announced research and £75m in funding to advance early and quick diagnosis of prostate cancer.

More than 60 clinical studies will be conducted to evaluate various treatment approaches, including precise radiotherapy, high-intensity focused ultrasound and cryotherapy.

The studies will test different supportive interventions, including exercise and dietary advice.

Set to enroll more than 40,000 patients over the coming five years, research will focus on higher risk groups, including men aged 50 and over, and those with a family history of the disease. This will be backed by £75m to support new research into early diagnosis and treatment.

The National Institute for Health Research (NIHR) Clinical Research Network chief executive Dr Jonathan Sheffield said: “The NIHR will work closely with the NHS, life sciences industry, charities and research funders to support the recruitment of 40,000 men into research studies over the next five years.

“This will provide more opportunities for earlier access to new drugs and therapies, which will ultimately lead to improved diagnoses and care in the future.”

The announcement comes as the Prime Minister confirmed the government will come forward with a fully funded, long-term plan for the NHS this year.

She will meet with NHS staff during a visit to Cambridgeshire – the first in a series of discussions as the government works with the health service to develop the plan.

May said: “Now in its 70th year, our NHS has a bright future – since last November, we have already committed £10bn in new funding, including a new pay deal for one million NHS workers.

“In fact, as part of our balanced approach to managing the economy we have increased spending on the health service every year since 2010. But I’m clear the way to secure the NHS’s future is having a long-term plan, with sustainable multi-year funding.”

The NHS has recently piloted a ‘one-stop cancer shop’ initiative to speed-up cancer diagnosis and identify the disease in its early stages.

10 April 2018

Mixed results for Merck and Incyte cancer drug trials

Incyte Corporation and Merck have announced that they are stopping trials of Incyte’s epacadostat in combination with Merck’s Keytruda in patients with unresectable or metastatic melanoma after an external Data Monitoring Committee (eDMC) review.

The review concluded that the Phase III ECHO-301/KEYNOTE-252 study did not meet the primary endpoint of improving progression-free survival in the overall population compared to Keytruda monotherapy. The study’s second primary endpoint of overall survival is also not expected to reach statistical significance.

Data from this study will be analysed and submitted for presentation at an upcoming scientific congress.

Incyte chief medical officer Dr Steven Stein said: “While we are disappointed that this study did not confirm the efficacy of epacadostat in combination with Keytruda in patients with unresectable or metastatic melanoma, data from ECHO-301/KEYNOTE-252, including analyses of an extensive biomarker panel, will contribute to our understanding of the role of IDO1 inhibition in combination with PD-1 antagonists, and may inform our broader epacadostat clinical development programme.

“We remain dedicated to transforming the treatment of cancer and will continue to explore how IDO1 inhibition and other novel mechanisms can potentially improve outcomes for patients in need.”

Epacadostat works by targeting and binding to IDO1, an enzyme responsible for the oxidation of tryptophan into kynurenine. By inhibiting IDO1 and decreasing kynurenine in tumour cells, epacadostat increases and restores the proliferation and activation of various immune cells.

The combination of epacadostat and immune checkpoint inhibitors has shown proof-of-concept in patients with unresectable or metastatic melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck and bladder cancer.

Keytruda is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumour cells. Keytruda is already approved in the US to treat some types of non-small cell lung cancer and skin and blood cancer.

Days after the combination therapy trials were halted, Merck announced that a Phase III study of Keytruda as a monotherapy for locally advanced or metastatic non-small cell lung cancer had met primary endpoints. The drug was shown to extend the lives of patients significantly compared to chemotherapy.

10 April 2018

Roche closes $1.9bn Flatiron Health acquisition

Roche has completed the acquisition of healthcare technology and services company Flatiron Health for $1.9bn.

The deal, which increases Roche’s existing 12.6% equity stake in Flatiron, will enable the companies to advance data-driven personalised healthcare in cancer.

Flatiron will continue operating as a separate legal entity and retain its existing business model, partnership network and overall objectives.

Roche plans to maintain the integrity of segregated patient protected health information, along with sales and marketing, provider-facing, and life science business activities.

When the original agreement was signed in February, Roche CEO Daniel O’Day said that the transaction was in line with the company’s personalised healthcare strategy.

O’Day said: “As a leading technology company in oncology, Flatiron Health is best positioned to provide the technology and data analytics infrastructure needed not only for Roche, but for oncology research and development efforts across the entire industry.

“A key principle of this is to preserve Flatiron’s autonomy and their ability to continue providing their services to all existing and future partners.”

Flatiron Health provides oncology-specific electronic health record software products and develops real-world evidence to aid cancer research.

The Flatiron platform enables cancer researchers and care providers to learn from the experience of every patient. Currently, Flatiron partners with over 265 community cancer clinics, six major academic research centres and 14 out of the top 15 therapeutic oncology companies.

Flatiron also partners with various firms and regulators in the industry to devise new methods to use real-world evidence in regulatory decision making.

9 April 2018

Johnson & Johnson to pay $37m after losing baby powder cancer case

Johnson & Johnson has lost a lawsuit that claimed baby powder manufactured by the company was responsible for a deadly cancer linked to asbestos.

The company, along with talc supplier Imerys SA, must pay at least $37m after a jury in New Jersey ruled that the product had been tainted by asbestos and this had led to the disease.

The plaintiff, Stephen Lanzo, claimed that using Johnson & Johnson baby powder had contributed to him developing mesothelioma, a type of cancer that develops in the outer layer of organs and is known to be caused by exposure to asbestos. He has been awarded $30m and his wife has been awarded $7m in damages.

According to Bloomberg, Lanzo’s lawyers produced files that suggested company officials had concerns that asbestos was tainting talc used in baby powder as early as 1969.

A jury will now assess whether the two companies should also pay punitive damages.

The company has been sued by around 6,600 women who make similar claims about the link between baby powder and ovarian cancer. Johnson & Johnson won a similar case in November last year, in which a woman from California claimed that baby powder had caused her to develop mesothelioma.

In August, the company lost a case in which a woman claimed that regular use of Johnson’s baby powder had caused her to develop terminal ovarian cancer. She received a record payout of $417m. However, the decision was overturned in October when a judge ruled that there was ‘insufficiency of the evidence as to the causation’.

Baby powder contains the clay mineral talc, which in its natural form can contain asbestos and is known to cause cancer when inhaled. Although the talc used in baby power is processed to be asbestos-free, there is a risk of cross-contamination during mining. It is not yet clear whether there is a link between using baby power and cancer as no large-scale studies have been carried out.

In a statement on their website, Johnson & Johnson said: “We firmly believe that Johnson’s baby powder is safe to use. Decades of safety reviews by independent researchers and scientists have shown that cosmetic talc is safe to use with no proven causal link to cancer.”

6 April 2018

New artificial enzyme employs light against bacteria

Researchers at RMIT University in Melbourne, Australia have developed an artificial enzyme that uses visible light to break down and destroy bacteria.

The NanoZymes work by combining light with moisture to create a biochemical reaction that results in OH radicals that break down bacteria.

When tested using visible light sources, the activity of these enzymes increased 20-fold, creating holes in the bacterial cells and killing them.

Researchers hope that in the future the enzymes could be activated by sunlight.

RMIT lead researcher Vipul Bansal said: “For a number of years we have been attempting to develop artificial enzymes that can fight bacteria, while also offering opportunities to control bacterial infections using external triggers and stimuli. Now we have finally cracked it.

“This next generation of nanomaterials are likely to offer new opportunities in bacteria free surfaces and controlling spread of infections in public hospitals.”

Researchers aim to use the NanoZymes against various bacterial infections such as E. coli and golden staph.

The NanoZymes work in a solution that mimics the fluid in a wound and could be sprayed onto surfaces.

They are also produced as powders to mix with paints, ceramics and other consumer products. This could mean bacteria-free walls and surfaces in hospitals.

Researchers also expect that the enzymes may help in developing self-cleaning toilet bowls.

They are currently transitioning from testing the technology in a lab environment to evaluating the long-term performance of the NanoZymes in consumer products.

6 April 2018

Boehringer and OSE Immunotherapeutics to develop cancer drug

Boehringer Ingelheim has formed an alliance with OSE Immunotherapeutics to develop a SIRP-alpha antagonist compound to treat advanced solid tumours.

Under the collaboration and licence agreement, the companies will work together on the monoclonal antibody OSE-172 that is currently in late preclinical development for multiple cancers.

SIRP-alpha is a receptor expressed by myeloid lineage cells and its inhibition is expected to prevent the binding of CD47 ligand to the receptor, causing cellular inhibitory effects.

Boehringer believes that OSE-172 can improve T cell activity and anti-tumour immunity.

Boehringer cancer immunology and immune modulation research global head Jonathon Sedgwick said: “A key area of focus is the identification of drugs that target myeloid cell immune regulatory receptors of which SIRP-alpha is a leading example.

“We are dedicated to developing ground-breaking, first-in-class therapies that can transform the lives of patients and help win the fight against cancer.”

Boeringher will acquire the global rights to develop, register and commercialise the compound. OSE Immunotherapeutics will obtain €15m upfront and up to €1m in potential short-term milestones after the launch of a Phase I clinical trial.

The company could receive more than €1.1bn upon reaching pre-specified development, commercialisation and sales milestones, plus royalties on worldwide net sales.

OSE Immunotherapeutics CEO Dominique Costantini said: “This partnership with Boehringer Ingelheim is a real recognition of the value of our innovative approach to treating cancer and will create an exciting new alliance to fuel the Phase I development of OSE-172.

“Boehringer Ingelheim’s expertise and insights will be invaluable as we step up the clinical development and work to commercialise this new treatment paradigm.”

5 April 2018

Stanford University devises new way to make noscapine drug

Bioengineers at Stanford University have devised a new method for fermentation-based production of noscapine, a cough suppressant and potential anticancer medicine.

Researchers engineered brewer’s yeast, a one-cell fungus, with 25 genes of enzymes obtained from medicinal plants, microorganisms and mammals to make the drug.

The new approach delivers an 18,000-fold increase in the output compared with the amount obtained by inserting only plant and rat genes into yeast.

The additional 100-fold improvement required for commercial viability can be achieved by replacing laboratory flasks with large-scale bioreactors.

Stanford University bioengineering professor Christina Smolke said: “This is a technology that’s going to change the way we manufacture essential medicines.”

Noscapine’s cough-suppressing capability was discovered in 1930. The drug was also found to be a potential oncology therapy during preclinical trials, where it exhibited less impact on healthy cells than currently available chemotherapy.

New natural techniques for the production of this medicine are necessary as currently opium poppy is the only feasible source; however, this is limited by expensive controls and regulations.

Noscapine obtained from the plant also takes a year to reach maturation stage, while the newly bioengineered yeast only needs three to four days, as there are three separate sections of the noscapine biosynthesis pathway incorporated into a single yeast strain.

Researchers used the CRISPR gene-editing tool to reconstruct the genes and allow them to better work with each other, increasing the production of a chemical in the yeast that ensures robust production of the drug.

Smolke added: “We’re no longer limited to what nature can make. We’re moving to an age where we can borrow nature’s medicine-manufacturing processes and, using genetic engineering, build miniature living factories that make what we want.”

Stanford has licensed the new technology to US-based Antheia, which is working towards commercialisation.

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